Status:
UNKNOWN
Oral Contraceptive vs Menstrual Cycle Ex Vivo Model
Lead Sponsor:
University of Toronto
Conditions:
Contraceptives, Oral
Sex Hormone
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
Despite comprising half the population, females are often left out of muscle research due to the impact of changing hormones during the menstrual cycle and when using oral contraceptives. This makes i...
Detailed Description
The aim of the study is to develop a non-invasive model using serum from both oral contraceptive users and non-users at various stages of their cycles, to understand if different cycle or pill stages ...
Eligibility Criteria
Inclusion
- BMI between 18.5-29.9 kg/m2 (I.e., non-obese).
- For OC users: on monophasic OCs for \> 3 months prior to study enrollment
- For non-OC users: regular menstrual cycles length (25-35 days) for at least 3 months prior to study and at least 6 months off of OCs.
Exclusion
- Chronic disease diagnosis (cardiovascular, thyroid, diabetes)
- Current or recent remission of cancer
- Regular use of NSAID (except low-dose aspirin), anticoagulants
- Use of prescription drugs that would impact metabolism, e.g. Statins, Lithium, Attention-Deficit/Hyperactivity Disorder (ADHD) medication.
- Insertion of intrauterine device (IUD) - exception: copper
- Use of ergogenic aids such as creatine
- Regular Tabacco use
- Use of illicit drugs (growth hormones, testosterone)
- For non-OC users: Use of oral contraceptives for \> 6 months prior to study enrollment - to ensure return to regular menstrual cycle.
Key Trial Info
Start Date :
August 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06124274
Start Date
August 9 2023
End Date
September 1 2024
Last Update
November 9 2023
Active Locations (1)
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1
Goldring Centre for High Performance Sport at the University of Toronto
Toronto, Ontario, Canada, M5S2C9